BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER LK SCR 3.5HEX 4.75X15 ST

    MDR report key: 9106386 · Received September 23, 2019

    Report

    Report Number
    0001825034-2019-04248
    Event Type
    Injury
    Date Received
    September 23, 2019
    Report Date
    January 7, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSD
    PMA / PMN Number
    K132239
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONSIDERED CONFIRMED AS MEDICAL RECORDS STATED THAT THE SCREW FRACTURED. THE X-RAY COULD NOT BE USED AS IT WAS OF LOW QUALITY. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THAT THE PATIENT UNDERWENT A LEFT REVISION APPROXIMATELY 2 YEARS AGO, WHILE THE INITIAL SURGERY WAS ABOUT 7 YEARS AGO.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: CATALOG #: 115396, COMP RVS CNTRL 6.5X30MM ST/RST, LOT # 448280, CATALOG #: 180556, COMP LK SCR 3.5HEX 4.75X45 ST, LOT # 938460, CATALOG #: 180551, COMP LK SCR 3.5HEX 4.75X20 ST, LOT # 084360, CATALOG #: 180551, COMP LK SCR 3.5HEX 4.75X20 ST, LOT # 541820, CATALOG #: 010000589, COMP RVRS 25MM BSPLT HA+ADPTR, LOT # 047030, CATALOG #: 115320, COMP RVRS SHLDR GLNSP STD 41MM, LOT # 162220, CATALOG #: EP-115397, E1 44-41 STD +3 HMRL BRG, LOT # 702990, CATALOG #: 115370, COMP RVS TRAY CO 44MM, LOT # 905390, CATALOG #: 113647, COMP PRIMARY STEM 7MM STD, LOT # 900310. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICES REMAIN IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-04247, 0001825034-2019-04249, 0001825034-2019-04250. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT REVISION COMPREHENSIVE REVERSE TOTAL SHOULDER APPROXIMATELY. SUBSEQUENTLY, ABOUT SEVEN ONE YEAR (1) SEVEN (7) MONTHS EXPERIENCED SHARP PAIN WHICH LASTED FOR SECONDS AND WAS IMPROVED. X-RAY SHOWED THAT THERE WAS A FRACTURED INFERIOR SCREW. THE PLAN IS TO MANAGE CONSERVATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896307 COMPREHENSIVE REVERSE SHOULDER LK SCR 3.5HEX 4.75X15 ST PROSTHEIS, SHOULDER HSD ZIMMER BIOMET, INC. N/A 278030

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SEE H10 NARRATIVE.